Thioridazine Hydrochloride

ANDA 88736, held by Heritage Pharma Avet. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88736 (Thioridazine Hydrochloride), held by Heritage Pharma Avet, was first approved by FDA on Jul 24, 1984, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 24, 1984
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jul 24, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride100MG · tablet;oral	Thioridazine Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Feb 23, 2017	Supplement 12Labeling · Standard review	Approved	None posted
Nov 3, 2015	Supplement 11Labeling	Approved	None posted
Aug 7, 1991	Supplement 7Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 8Manufacturing	Approved	None posted
Aug 9, 1990	Supplement 9Labeling	Approved	None posted
Dec 21, 1988	Supplement 3Manufacturing	Approved	None posted
Dec 21, 1988	Supplement 4Manufacturing	Approved	None posted
Dec 21, 1988	Supplement 5Manufacturing	Approved	None posted
Jul 24, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88736
Drugs@FDA: Overview at FDA
Company: Heritage Pharma Avet

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters